| Customer verification | May sell only to licensed buyers |
|---|---|
| Records to keep | 2 years |
| Separate device or DME distributor license | No separate license |
What Massachusetts requires before you ship
Massachusetts lets distributors sell prescription drugs only to buyers who are licensed or authorized to receive them, which means checking the license first. A licensed wholesaler may not sell or deliver drugs to any unauthorized person. The rule does not say how to check, but you cannot follow it without confirming that each customer is authorized. Records must also include the purchaser's name and address.
Who counts as an authorized buyer: The rule does not define 'authorized person'. In practice it means persons allowed by Massachusetts law to receive drugs, such as licensed pharmacies, practitioners, hospitals and other licensed wholesalers.
"shall not sell or deliver drugs to any unauthorized person, whether upon prescription, at retail, or otherwise." 247 CMR 7.03(2)
Records to keep
Wholesalers must keep complete and accurate records of every receipt and distribution of prescription drugs. Records must show the source, or for sales the purchaser's name and address, along with the identity and quantity of drugs and the dates. They must be available for inspection for 2 years after the drugs are disposed of. Records kept off site that cannot be pulled up electronically must be produced within 2 working days.
Source: 247 CMR 7.04(6)
Licenses a distributor needs in Massachusetts
Prescription drug wholesale distributor
No one may sell, distribute or deliver drugs at wholesale in Massachusetts without a license. Board rules require every wholesale distributor located in Massachusetts to be licensed by the Board before it starts. The application must be signed under oath before a notary. A separate license is needed for each location. The rule's text applies to distributors located in Massachusetts.
Source: M.G.L. c. 112, § 36A; 247 CMR 7.01, 7.02
Medical device and DME distributors
No Massachusetts license for prescription device or DME distributors was found. 247 CMR 7.00 covers prescription drugs. A secondary source mentions a device manufacturer registration with the Drug Control Program, but we could not confirm it from an official source.
Controlled substances
A wholesale drug business may not handle controlled substances until it has a state controlled substance registration under M.G.L. c. 94C. The Board issues it to businesses that qualify for a wholesale druggist license. A registered wholesaler may distribute only the controlled substance classes it is registered for.
Source: 247 CMR 11.01, 11.03, 11.10; M.G.L. c. 94C
Where to look up a Massachusetts license
- Pharmacies and pharmacy permits: Massachusetts Board of Registration in Pharmacy
- Physicians and other practitioners: Massachusetts Board of Registration in Medicine
- NPI: NPPES NPI Registry
- DEA registrations: DEA Diversion Control Division
Federal rules that apply in every state
- A prescription device "is to be sold only to or on the prescription or other order of such practitioner," or to a business lawfully distributing it (21 CFR 801.109).
- A prescription drug wholesale distributor's trading partners "may be only authorized trading partners," which for a pharmacy means one licensed under state law (21 U.S.C. 360eee-1(c)(3)).
How WorkdID handles Massachusetts accounts
WorkdID by Workd checks every Massachusetts customer you sell to against the state's pharmacy and medical boards, the NPI registry, and the DEA, every day. It flags an expiration or a board action within a day of posting, and in Workd order entry it can hold the order until your compliance team clears the account. Every check is saved with the date and the board record, so your Massachusetts file is ready when someone asks for it.
Other states
Alabama · Alaska · Arizona · Arkansas · California · Colorado · Connecticut · Delaware · Florida · Georgia · Hawaii · Idaho · Illinois · Indiana · Iowa · Kansas · Kentucky · Louisiana · Maine · Maryland · Michigan · Minnesota · Mississippi · Missouri · Montana · Nebraska · Nevada · New Hampshire · New Jersey · New Mexico · New York · North Carolina · North Dakota · Ohio · Oklahoma · Oregon · Pennsylvania · Rhode Island · South Carolina · South Dakota · Tennessee · Texas · Utah · Vermont · Virginia · Washington · West Virginia · Wisconsin · Wyoming